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System Engineer Resume

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PROFESSIONAL SUMMARY

  • 5+ years of experience in implementing and validating FDA regulated mission critical GxP IT Systems delivery model.
  • Implemented and Validated E-Submissions system such as eCTDXPress, ISIPublisher and VLM for large number of pharmaceutical clients.
  • Strong knowledge of technical requirements for eCTD submissions.
  • Responsible for authoring, reviewing and executing Validation Documents such as IQ/OQ/PQ, Master Validation Plan, Master Test Plan, Change Control Test Plan, Test Summary Report, IQ/Validation Summary Report, Deviation Form and Traceability matrix.
  • Team Player with the positive attitude and ability to learn in a fast paced environment.
CERTIFICATIONS
  • Certification in eCTDXPress software for Pharmaceutical Industry, developed by Image Solutions Inc.
SUBMISSION EXPERIENCE
  • Knowledge of FDA guidance, eCTD, GAMP4 and 21 CFR Part 11.
  • Reg-Ops Training in submission processes, parts and FDA regulations.
TRAINING
  • Training in eCTDXPress, ISIToolBox, ISIPublisher, ISIRender, ISIRegTracker and VLM.
  • Successful Completion of all ISI’s Online Training SOP’s.
  • GxP (Good Testing, Documentation Practices).
  • Attribute Mapping Workshop.
EDUCATION
  • Master of Science in Computer Science
  • Master of Science in Software Engineering
TECHNICAL SKILLS

Languages : C, C++, Java, SQL, PL/SQL.
Database Systems : Oracle 9i, 10g, XE, MS SQL Server 2005/2008.
Tools : SQL Server Management Studio Express, SQL Developer.
Publishing Software : eCTDXPress, ISIPublisher, Virtual Link Manager, ISI
Submission Manager, ISIToolBox, ISIWriter, ISIRender.
Document Management System: Documentum, Live link, SharePoint, IBMScore, FirstDoc.
Electronic Submission Formats: eCTD, CTD, eNDA, eBLA, eIND, Study CTD and MAA.
Operating System : ESX Servers 3.5/4.0, Windows XP/NT/98/2000/Server
2003/Windows 7.
Software Packages : MS Office Suite 97/2003/2007(Word, Excel, PowerPoint,
Access, Outlook), MS Visio, Adobe Acrobat, Crystal Reports.
Others : Open Air, Axosoft On Time, Breeze, Adobe Connect.

ACHIEVEMENTS
  • Elected as EOM (Employee of the Month) for the month of September 09 and March 10 in Software Operations Division, Image Solutions Inc.
  • Identified as a key employee in implementing SaaS (Software as a Service) and PRISSM projects for major clients on behalf of ISI/CSC.

WORK EXPERIENCE

Employer : Confidential,
Location : Whippany, NJ.
Duration : Jan ’08 – Till Date.
Role : Implementation / Validation Lead.
Description :Image solutions Inc provides a wide range of Regulatory suite Products for pharmaceutical companies to process the health care documents to the regulatory submissions. eCTDXPress software is a web-based solution for managing, compiling, reviewing, registering and archiving eCTD submissions for the use of pharmaceutical companies to get their new drug approved by FDA.

Responsibilities:

Sr. Validation Lead, Regulatory Solutions Group, CSC Nov 10 – Till Date

  • Working with Quality/Validation Management in developing and implementing product and process validation protocols to ensure compliance to regulatory validation requirements, internal company standards and industry practices.
  • Solid Knowledge in current eCTD compilation and publishing software packages (ISI eCTDXPress, ISI Publisher, VLM and ISI Toolbox).
  • Involved in authoring the SOWs, Project Plans, and Project Schedule, defining the Roles & Responsibilities, Communication Plans, and Risk Management Plans.
  • Performed verifications (i.e. smoke tests and Adhoc Tests) to verify the code deployment in the Test and pre-production system.
  • Proficient in creating and re-modeling Change Control Process, Configuration Management, Standard Operating Procedures (SOP’s), Disaster Recovery and Business Continuity Plan for large scaled FDA regulated systems.
  • Expertise in writing/analyzing User Requirements, Functional Requirements and System Requirements Specification documents and developed appropriate Test Plans and Test Cases.
  • Developing and Conducting User Acceptance Testing (UAT) and documentation of Test Cases for new application releases and hot fixes.
  • Experience in using bug tracking tools such as On Time by Axosoft, defect tracking with development team to verify bug fixes and updating bug report.
  • Validated eCTDXPress and ISIPublisher System integrated with Documentum, Live link, File Share, Share Point against SQL and Oracle Databases.
  • Identify defects in the scripts, report and record the deviations in Incident Form and Incident Log. Report status to Test Manager and work with the manager to resolve issues.
  • Assist in dry running various test scripts to ensure quality of the product.
  • Interacted with business representatives, software developers and other support groups to deliver the scripts.
  • Customized scripts for the clients as per their environment setup, methodology, needs and created different test scenarios to test the Functional and User requirement.
  • Hands on Experience in creating comprehensive test cases and scenarios to validate new or enhanced functionality. This includes creating test data and expected results.
  • Executed IQs/OQs and ensured that the system performed the required functions and behaved correctly and consistently in its intended operating environment.
  • Set up Test Strategies, Entrance/Exit criteria and secured the sign off from the project team on it. This includes MVP, MTP, IOQP, TSR, VSR documents.
  • Creation of PQ scripts for the given URS.
  • Worked on formatting all validation documents as per the GAMP4/5 guidelines.
  • Proven ability to communicate effectively with all levels of management with excellent written, oral communication and interpersonal skills.

System Engineer, Software Operations Division, Confidential,Jan 08 – Oct 10

  • Involved in addressing Implementation issues for more than 20 clients including Forest Labs, Mylan, Santen, PTC, GE, Stryker, Merck, Spectrum and URL on behalf of ISI.
  • Participated in project kick-off meetings, collects Business User Requirements, authored IQ Roadmap and System Design Specification documents.
  • Scheduled and managed deployment and upgrade of Regulatory Publishing tools. This includes analyzing and designing global system architectures, implementing systems by following client’s validation methodology and providing support till the client goes LIVE.
  • Performed Data Migration of submissions from various softwares into ISI eCTDXPress application and database migration from eCTDXPress-v2.x to ecTDXPress-v3.2.6 (RSS SP3).
  • Provided consulting services including Technical consulting, business process development and software education.
  • Responsible for executing Installation qualification, Operational qualification and Process qualification protocols at the time of product installation/validation.
  • Responsible for Internal and client site Performance testing with new release of ISI Product (eCTDXPress and ISIPublisher).
  • Created and executed validation test scripts and documented test results in accordance with SOPs.
  • Provided timely and accurate progress information to support project status reports.
  • Update internal documentation with latest patches and hot fixes.
  • Resolves / Escalates client issues to the R&D team for the fix.
  • Develop documentation including test plans, installation instructions, internal release notes, and design documents.
  • Issue logging, tracking, analysis, reporting and management.
  • Oversee project budgets and ensure that internal change orders are managed properly and that all projects are executed to optimize profitability.
  • Participated in formal reviews of product documentation.
  • Evaluates and tests new or modified software programs and software development procedures used to verify that programs function according to user requirements and conform to establishment guidelines.

Worked as a Java Developer – Intern in Alpha Images, Bangalore from June 2003 to Nov 2003.
Worked as a Java Developer – Intern in SRM InfoTech, Chennai from Nov 2004 to Apr 2005.
Worked as a Crystal Reports developer in Vel Infosys, India from may 2005 to Apr 2006.
Worked as a Jr. Validation Engineer - Intern in ISI, NJ from Apr 07-Dec 07.

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